Juping Shen,Nanjing Sanhome Pharmaceutical Co., Ltd.,Vice GM of Quality

03/2003 – 03/2006： _MBA, East-South University

09/1987 – 06/1991： _Chinese Pharmaceutical University

04/2016~Nanjing Sanhome Pharmaceutical Co., Ltd.,Vice GM of Quality

01/2016-03/2016Eisai (Liaoning) Pharmaceutical Co., Ltd.,Plant Manager

04/2013-12/2015Eisai China Pharmaceutical Inc.,Senior Project Director

02/2012-03/2013Jiansu CHIA TIANQIANpharmaceutical Co. Ltd.,Group Quality Director

07/2007 – 01/2012Suzhou Otsuka PharmaceuticalCo. Ltd,Director of QualityManagement Department&R&D

01/2006-06/2007 Gudong Otsuka Pharmaceutical Co. Ltd,Director of Quality Management Department

07/1991 – 12/2005 Sino-Swed Pharmaceutical Co. , Ltd,Deputy manager of Development Dept. /Validation manager of phase II project./Supervisor & shift manger in Production Dept.

Major Abilities/主要能力:

² Master China and foreign GMP regulation

² Rich experience of China GMP inspection， _EU GMP and Japan GMP audit.

² Rich experience of aseptic process, equipments and quality assurance. Strong team building, team leading ability

² Rich experience of project management, including project design, construction, inspection and audit. Control the project safety, quality, time schedule and budget strictly.

² One of the main authors and reviewers of China new GMP regulation. Being guest speaker for SFDA and provincial GMP and quality training.

² New GMP guideline 《 _sterile product》, Deputy group leader，one of the main auditors for the guideline.

² 《Pharmaceutical Pre-Approval Inspections》 _experts audit member

² Member of CPAPE experts group

² Member of ISPE

沈菊平 _

03/2003 – 03/2006：东南大学 _工商管理硕士 _

09/1987 – 06/1991：中国药科大学 _药学专业 _

04/2016~南京圣和药业有限公司,质量副总经理

01/2016-03/2016卫材(辽宁)制药有限公司,工厂长

04/2013-12/2015卫材(中国)药业有限公司,高级项目总监

02/2012-03/2013江苏正大天晴药业有限公司，集团质量总监

07/2007 – 01/2012苏州大冢制药有限公司,品质管理部和研发部部长

01/2006-06/2007广东大冢制药有限公司，品质管理部部长

07/1991 – 12/2005华瑞制药有限公司,研发副经理/项目验证经理/生产主管、值班经理

Major Abilities/主要能力:

² 熟悉中国及国外主要GMP法规。

² 有丰富的中国GMP、欧盟GMP和日本GMP等检查和认证的经验，并有许多成功案例。

² 对药品的生产、质量、设备、验证和工艺有非常丰富的理论知识和实践经验，特别是无菌药品。

² 丰富的项目管理经验，并有多次成功完成无菌药品项目的从项目设计、施工、验收的经验，严格执行项目的安全、质量、进度和预算的管理。

² 中国2010版GMP的主要起草者和修订者之一，为SFDA及各省市药监系统实施几十场的公开讲座和培训。

² 配套GMP实施指南《无菌药品》的主要编委，同时协助修订《质量管理体系》、《公用工程及设施》指南。

² 《药品注册批准前检查》专家审校成员

² 中国医药设备工程协会专家组成员，专家委员会主任

² ISPE 会员